PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

NCT ID: NCT06696742

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2029-02-01

Brief Summary

This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

Detailed Description

This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

This study is divided into two parts. One is the patients with neoadjuvant therapy. After 3 cycles of neoadjuvant therapy, to observe whether the patients with Clostridium butyricum live tablets have better neoadjuvant therapy efficacy. The other was in patients with adjuvant therapy to see if adjuvant therapy combined with Clostridium butyricum could prolong the patient's prognosis.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GC+anti-PD1+Clostridium butyricum

For Neoadjuvant therapy

• GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles.

• PD1: Tislelizumab 200mg every 21 days for 3 cycles. ③Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day.

For Adjuvant Therapy:

①PD1: Tislelizumab 200mg every 21 days for 1-2 year.

②Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day.

Group Type: EXPERIMENTAL

Clostridium Butyricum Tablets

Intervention Type: DRUG

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

GC+anti-PD1

For Neoadjuvant therapy

①GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles.

②PD1: Tislelizumab 200mg every 21 days for 3 cycles.

For Adjuvant Therapy:

①PD1: Tislelizumab 200mg every 21 days for 1-2 year.

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

Gemcitabine and Cisplatin

Interventions

Clostridium Butyricum Tablets

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

Intervention Type: DRUG

Cisplatin

Gemcitabine and Cisplatin

Intervention Type: DRUG

Other Intervention Names

Cisplatin; Gemcitabine; Gemcitabine

Eligibility Criteria

Inclusion Criteria

For Neoadjuvant therapy:

• T2-T4aN0M0 bladder patients

For Adjuvant therapy:

• Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

Exclusion Criteria

• The researchers evaluated the patients who could not tolerate radical surgery;
• Previously received systemic chemotherapy or immunotherapy;
• There are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants;
• Have had major surgery or major trauma within 28 days before joining the group;
• Vaccinated with live vaccine within 28 days before joining the group.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Lu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Yang

Role: CONTACT

yangxiao2915@163.com

+8613951813528

Facility Contacts

Xiao Yang

Role: primary

yangxiao2915@163.com

+8613951813528

Other Identifiers

2024-SR-371

Identifier Type: -

Identifier Source: org_study_id